MX2017000137A - Fast acting orally disintegrating film. - Google Patents
Fast acting orally disintegrating film.Info
- Publication number
- MX2017000137A MX2017000137A MX2017000137A MX2017000137A MX2017000137A MX 2017000137 A MX2017000137 A MX 2017000137A MX 2017000137 A MX2017000137 A MX 2017000137A MX 2017000137 A MX2017000137 A MX 2017000137A MX 2017000137 A MX2017000137 A MX 2017000137A
- Authority
- MX
- Mexico
- Prior art keywords
- orally disintegrating
- fast acting
- disintegrating film
- amount
- odf
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4178—1,3-Diazoles not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7007—Drug-containing films, membranes or sheets
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Abstract
A fast acting orally disintegrating film (ODF) for treatment of various medical conditions including emesis that has a simple formulation, easy to manufacture and has similar pharmacokinetic profile to currently commercially available products is provided. The ODF comprises an active pharmaceutical ingredient such as ondansetron or a pharmaceutical acceptable salt thereof in an amount of 2 to 24 mg, at least one hydrophilic film forming polymer in an amount of at least 8% by weight of the film, at least one hydrophilic film forming polymer having a molecular weight of 5000 to 50000Da, and a water soluble excipient.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201462016643P | 2014-06-24 | 2014-06-24 | |
PCT/US2015/037045 WO2015200233A1 (en) | 2014-06-24 | 2015-06-23 | Fast acting orally disintegrating film |
Publications (1)
Publication Number | Publication Date |
---|---|
MX2017000137A true MX2017000137A (en) | 2017-04-27 |
Family
ID=54938716
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
MX2017000137A MX2017000137A (en) | 2014-06-24 | 2015-06-23 | Fast acting orally disintegrating film. |
Country Status (15)
Country | Link |
---|---|
US (2) | US10456378B2 (en) |
EP (1) | EP3160589B1 (en) |
JP (1) | JP6748642B2 (en) |
KR (1) | KR20170023108A (en) |
CN (1) | CN106714907B (en) |
AU (1) | AU2015280262B2 (en) |
CA (1) | CA2953546A1 (en) |
ES (1) | ES2966853T3 (en) |
HK (1) | HK1232170A1 (en) |
MX (1) | MX2017000137A (en) |
MY (1) | MY189110A (en) |
NZ (1) | NZ727834A (en) |
RU (1) | RU2016150527A (en) |
SG (1) | SG11201610358XA (en) |
WO (1) | WO2015200233A1 (en) |
Families Citing this family (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
TWI704932B (en) * | 2016-06-30 | 2020-09-21 | 泰合生技藥品股份有限公司 | A fast acting orally disintegrating film for administration of local anesthesia |
RU2018100879A (en) * | 2016-06-30 | 2020-07-30 | Тахо Фармасьютикалз Лтд. | FAST DISPOSING IN THE ORAL CAVITY FILM FOR LOCAL ANALYSIS |
WO2020006073A1 (en) | 2018-06-28 | 2020-01-02 | Arx, Llc | Dispensing method for producing dissolvable unit dose film constructs |
EP3846778A1 (en) | 2018-09-07 | 2021-07-14 | Aquestive Therapeutics, Inc. | Oral film compositions and dosage forms having precise active dissolution profiles |
JP6905035B2 (en) * | 2019-11-29 | 2021-07-21 | Nissha株式会社 | Manufacturing method of edible film, film preparation and edible film |
EP4119123A1 (en) | 2021-07-14 | 2023-01-18 | G.L. Pharma GmbH | Orally disintegrating film composition comprising buprenorphine |
EP4119124A1 (en) | 2021-07-14 | 2023-01-18 | Vektor Pharma TF GmbH | Microemulsion containing orally disintegrating film compositions with adjustable physical and rheological properties |
Family Cites Families (25)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US8663687B2 (en) | 2001-10-12 | 2014-03-04 | Monosol Rx, Llc | Film compositions for delivery of actives |
US7357891B2 (en) | 2001-10-12 | 2008-04-15 | Monosol Rx, Llc | Process for making an ingestible film |
US7666337B2 (en) | 2002-04-11 | 2010-02-23 | Monosol Rx, Llc | Polyethylene oxide-based films and drug delivery systems made therefrom |
AU2002255196A1 (en) | 2002-04-18 | 2003-10-27 | Dr. Reddy's Laboratories Ltd. | Rapidly dispersing solid oral compositions |
WO2003097103A1 (en) | 2002-05-16 | 2003-11-27 | Kyukyu Pharmaceutical Co.,Ltd. | Quickly soluble film preparations |
DE10338544B4 (en) * | 2003-08-19 | 2017-08-31 | Janssen Pharmaceutica N.V. | Buccal formulations of galanthamine and their applications |
US7390503B1 (en) | 2003-08-22 | 2008-06-24 | Barr Laboratories, Inc. | Ondansetron orally disintegrating tablets |
WO2005039499A2 (en) * | 2003-10-24 | 2005-05-06 | Adhesives Research, Inc. | Rapidly disintegrating film |
US8658201B2 (en) | 2004-01-30 | 2014-02-25 | Corium International, Inc. | Rapidly dissolving film for delivery of an active agent |
US9884014B2 (en) * | 2004-10-12 | 2018-02-06 | Adare Pharmaceuticals, Inc. | Taste-masked pharmaceutical compositions |
DE102005033943A1 (en) * | 2005-07-20 | 2007-02-22 | Hexal Ag | Non-spitting, oral, fast-disintegrating film for a neuroleptic |
PT1998762E (en) * | 2006-03-16 | 2010-11-30 | Novartis Ag | Solid dosage form containing a taste masked active agent |
US8580830B2 (en) | 2006-10-02 | 2013-11-12 | Labtec Gmbh | Non-mucoadhesive film dosage forms |
US20080131467A1 (en) | 2006-11-30 | 2008-06-05 | Dennis Nelson | Film-coated solid dosage form |
US8900634B2 (en) | 2008-11-03 | 2014-12-02 | Nal Pharmaceuticals, Ltd. | Diethylstilbestrol dosage form and methods of treatment using thereof |
US8715715B2 (en) * | 2008-11-03 | 2014-05-06 | Nal Pharmaceuticals Ltd. | Dosage form for insertion into the mouth |
US20100297232A1 (en) * | 2009-05-19 | 2010-11-25 | Monosol Rx, Llc | Ondansetron film compositions |
KR101074271B1 (en) * | 2009-06-25 | 2011-10-17 | (주)차바이오앤디오스텍 | Fast dissolving oral dosage form containing steviosides as a taste masking agent |
EP2722045B1 (en) * | 2009-11-18 | 2016-07-06 | Helsinn Healthcare SA | Compositions for treating centrally mediated nausea and vomiting |
JP2013515782A (en) | 2009-12-28 | 2013-05-09 | モノソル アールエックス リミテッド ライアビリティ カンパニー | Orally administrable film formulation containing ondansetron |
US20110237563A1 (en) | 2010-03-23 | 2011-09-29 | Dominique Costantini | Fast dissolving drug delivery systems |
WO2012053006A2 (en) * | 2010-10-18 | 2012-04-26 | Panacea Biotec Ltd | Improved oral fast dissolving films comprising combination of polymers and method of preparation thereof |
NZ612686A (en) * | 2010-12-16 | 2015-11-27 | Cynapsus Therapeutics Inc | Sublingual films |
KR101303479B1 (en) * | 2011-07-28 | 2013-09-06 | (주)씨엘팜 | Composition for edible film and pharmaceutical preparation for edible film containing drugs |
US20140073678A1 (en) * | 2012-09-12 | 2014-03-13 | Monosol Rx, Llc | Anti-pain and anti-nausea and/or vomiting combinatorial compositions |
-
2015
- 2015-06-23 KR KR1020177001702A patent/KR20170023108A/en not_active Application Discontinuation
- 2015-06-23 SG SG11201610358XA patent/SG11201610358XA/en unknown
- 2015-06-23 ES ES15811604T patent/ES2966853T3/en active Active
- 2015-06-23 NZ NZ727834A patent/NZ727834A/en unknown
- 2015-06-23 RU RU2016150527A patent/RU2016150527A/en not_active Application Discontinuation
- 2015-06-23 CA CA2953546A patent/CA2953546A1/en not_active Abandoned
- 2015-06-23 WO PCT/US2015/037045 patent/WO2015200233A1/en active Application Filing
- 2015-06-23 JP JP2017521070A patent/JP6748642B2/en active Active
- 2015-06-23 MY MYPI2016002269A patent/MY189110A/en unknown
- 2015-06-23 EP EP15811604.6A patent/EP3160589B1/en active Active
- 2015-06-23 MX MX2017000137A patent/MX2017000137A/en unknown
- 2015-06-23 AU AU2015280262A patent/AU2015280262B2/en active Active
- 2015-06-23 CN CN201580045857.8A patent/CN106714907B/en active Active
-
2016
- 2016-11-14 US US15/351,368 patent/US10456378B2/en active Active
-
2017
- 2017-06-15 HK HK17105953.5A patent/HK1232170A1/en unknown
-
2019
- 2019-09-13 US US16/569,979 patent/US11304933B2/en active Active
Also Published As
Publication number | Publication date |
---|---|
EP3160589B1 (en) | 2023-10-25 |
HK1232170A1 (en) | 2018-01-05 |
CN106714907A (en) | 2017-05-24 |
ES2966853T3 (en) | 2024-04-24 |
JP2017520625A (en) | 2017-07-27 |
KR20170023108A (en) | 2017-03-02 |
SG11201610358XA (en) | 2017-01-27 |
CN106714907B (en) | 2021-07-30 |
CA2953546A1 (en) | 2015-12-30 |
US10456378B2 (en) | 2019-10-29 |
US20200000773A1 (en) | 2020-01-02 |
AU2015280262B2 (en) | 2020-08-13 |
MY189110A (en) | 2022-01-26 |
RU2016150527A (en) | 2018-07-26 |
AU2015280262A1 (en) | 2017-01-12 |
US11304933B2 (en) | 2022-04-19 |
US20170056374A1 (en) | 2017-03-02 |
JP6748642B2 (en) | 2020-09-02 |
WO2015200233A1 (en) | 2015-12-30 |
EP3160589A4 (en) | 2018-02-21 |
RU2016150527A3 (en) | 2020-02-20 |
EP3160589A1 (en) | 2017-05-03 |
NZ727834A (en) | 2020-08-28 |
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